Status:
RECRUITING
Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
Lead Sponsor:
Alpha Tau Medical LTD.
Conditions:
Skin Cancer
Cutaneous Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
Detailed Description
This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds...
Eligibility Criteria
Inclusion
- Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
- SCC
- BCC
- Lentigo maligna melanoma (Dubreuilh melanoma)
- Carcinosarcoma
- Acceptable tumor locations include the following:
- Skin (facial, scalp, extremities, torso)
- Lips
- Eyelids
- Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
- Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
- Measurable disease according to RECIST v1.1.
- Subjects over 18 years old.
- Subjects' ECOG Performance Status Scale is \< 2.
- Subjects' life expectancy is more than 6 months.
- Platelet count ≥100,000/mm3.
- International normalized ratio of prothrombin time ≤1.8.
- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
- Subjects are willing to sign an informed consent form
Exclusion
- Subject has a tumor with histology of one of the following:
- Keratoacanthoma
- Merkel cell carcinoma
- Sarcoma other than carcinosarcoma
- Metastatic disease (according to the TNM staging system - M1 patients are excluded)
- Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
- Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
- High probability of protocol non-compliance (in opinion of investigator).
- Subjects not willing to sign an informed consent.
- Women who are pregnant or breastfeeding.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04068155
Start Date
April 1 2022
End Date
January 1 2025
Last Update
November 22 2024
Active Locations (2)
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1
CHU Grenoble Alpes
Grenoble, France, 38700
2
Centre Léon Bérard
Lyon, France, 69008